An interventional study of Propofol in Critical Illness, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
Systematic evaluation of pain, agitation and delirium in ICU-patients is recommended and deep sedation should be avoided. Sedation is still monitored with clinical assessments, like RASS. The Responsiveness Index (RI) is a recently described method for ICU sedation monitoring. It is based on processed frontal EMG and reflects the interaction between a patient's conscious state and the intensity and frequency of stimulations during treatment. RI has not been randomly compared to RASS to titrate sedation to target at a clinically adequate sedation state. In this open randomized controlled pilot study of 32 critically ill, mechanically ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy of RI based sedation compared to standard RASS based titration of sedation. Investigators hypothesize first that RI controlled sedation will be safe and, second that RI controlled sedation will associate with increased number of ventilator free days alive in 30 days without excess adverse events.
Sedation of intensive care patients is needed for patient's safety but deep sedation is associated with adverse outcomes. Frontal electromyogram based Responsiveness Index (RI) aims to quantify patient's arousal. RI monitoring together with staff education may have potential to improve sedation quality. Investigators will evaluate the safety of RI based sedation versus standard care using Richmond Agitation-Sedation Scale (RASS) for sedation.
Methods: randomized study, critically ill adult patients with mechanical ventilation and administration of sedation to either RI- or RASS-guided sedation. Propofol (and midazolam combined with if needed) as a hypnotic drug and oxycodone as an analgesic drug. Investigators will follow standardized sedation protocol in both groups to achieve the predetermined target sedation level: either RI 40-80 (RI-group) or RASS -3-0 (RASS group). RI measurement is continuous in both groups, but blinded in the RASS group. Accordingly, RI group is blinded to RASS assessments. State Entropy (SE) will register in both groups.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 32 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
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Sedation is guided with RASS. Targeted sedation level is RASS -3 - 0. Propofol: an initial rate of 2.4 mg/kg/h for one hour. Thereafter, the infusion rate of propofol is 0.8-4 mg/kg/h to reach or maintain the target RASS score. Propofol bolus of 20-40 mg is allowed. Oxycodone as 3-6 mg boluses for pain management. Other opiates are not allowed. Midazolam may given if the maximum dose of propofol is reached and pain management by oxycodone restricted achievement of the target sedation level. Midazolam will supply intravenously in boluses of 1-2 mg (based on the weight of the patient), starting at 3 boluses/h for the first hour. Dexmedetomidine and other sedatives are not allowed.
Drug: Propofol
Sedation is guided with RI. Targeted sedation level is RI 40-80. Propofol: an initial rate of 2.4 mg/kg/h for one hour. Thereafter, the infusion rate of propofol is 0.8-4 mg/kg/h to reach or maintain the target RI score. Propofol bolus of 20-40 mg is allowed. Oxycodone as 3-6 mg boluses for pain management. Other opiates are not allowed. Midazolam may given if the maximum dose of propofol is reached and pain management by oxycodone restricted achievement of the target sedation level. Midazolam will supply intravenously in boluses of 1-2 mg (based on the weight of the patient), starting at 3 boluses/h for the first hour. Dexmedetomidine and other sedatives are not allowed.
Drug: Propofol
Sedation targeted to RASS -3-0 or RI 20-40
Also known as: Oxycodone, Midazolame
Number of patients with sedation or sedation monitoring related predetermined adverse events
Predetermined adverse events hypotension, hypertension, tachycardia, tachypnea, anxiety, unintended catheter removal, gas exchange deficiency, skin irritation caused by electrodes, hemodynamic instability
Time frame: Up to 96 hours (starting when RI-monitoring begins)
Increased ventilator free days
Time alive without mechanical ventilation
Time frame: 30 days
Ran from Mar 2013 to primary completion in Aug 2017, 53 months.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 53 months is above that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Propofol
Helsinki University Central Hospital →